MRI and PET-CT for Radiotherapy Planning for Head and Neck Cancer

Radiotherapy is commonly used to treat advanced cancers of the head and neck, aiming for cure while preserving patients' quality of life including their ability to speak and swallow. In order to reduce the potentially major side effects of treatment, it is essential that the highest doses of radiotherapy are targeted to the main bulk of the tumour. At present a computerized tomography (CT) scan is used by the cancer specialist to identify the tumour for planning the radiotherapy treatment. The investigators know that other types of scan including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans are better than CT scans at showing areas involved by the cancer. However, radiotherapy cannot be directly planned on these types of scans. The aim of this study is to explore whether PET and MRI scans can be combined with CT scans to more accurately identify the tumour target. In addition, this study will explore whether PETCT and MRI scans may used to adjust radiotherapy to how well a tumour is responding during a course of radiotherapy. If the radiotherapy planning process can be improved in these ways, the investigators hope future patients will benefit by more chance of cure with a reduction in the side effects of treatment. The study aims to recruit 16 patients. All patients within the study will undergo a PETCT and an MRI scan prior to starting treatment as part of the study. A subgroup of 8 patients will undergo additional imaging at two timepoints during the course of their radiotherapy. The study is noninterventional and patients' standard treatment will not be affected by their participation in the study.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥18
WHO Performance status 02
Histologically proven squamous cell carcinoma of the head and neck region
Clinical decision made to proceed with a course of radiotherapy of curative intent of 6670Gy in 3335 fractions over six and a half to seven weeks with or without concurrent chemotherapy
Measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging
Able to provide fully informed written consent
Able to lie flat for 1 hour
Not be pregnant or breast feeding. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal.

Exclusion criteria

Hypersensitivity to fluorine-18 FDG
Hypersensitivity to iodinated contrast media or Gadolinium
Poorly controlled diabetes
Acute renal failure or moderate renal impairment (estimated glomerularb filtration rate < 30 mL/min)
Contraindication to MRI imaging, including cardiac pacemaker or presence of MRI incompatible metalwork
Claustrophobia precluding MRI imaging
Uncontrolled pain
Urinary incontinence
Female patients must not be pregnant and if of child bearing age using adequate contraception
Breast feeding
Serious psychiatric comorbidity

Treatment and study plan

MRI scan

Procedure

PET-CT Scan

Procedure

No intervention

Other

Primary outcomes

Feasibility of utilising MRI images in head and neck radiotherapy planning.

Time frame: 40-60 minutes

Determine whether MRI images in head and neck radiotherapy can be used to modify the tumour target volume during radiotherapy.
Feasibility of utilising PET-CT images in head and neck radiotherapy planning.

Time frame: 2 hours

Determine whether PET-CT images in head and neck radiotherapy can be used to modify the tumour target volume during radiotherapy.

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Registry information

Official study title

A Pilot Study Investigating the Use of Co-registered 18FDG-PET-CT and MRI for Radiotherapy Planning in Locally Advanced Head and Neck Squamous Cell Carcinoma

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Oct 24, 2014
Registry last updated: Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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